Direct improvement of quality of life in colorectal cancer patients using a tailored pathway with quality of life diagnosis and therapy (DIQOL): study protocol for a randomised controlled trial.

Background: Medical treatment in patient-centred care in oncology is broadly managed and regulated in terms of guideline development, cancer centres, and quality assurance by cancer registries. In contrast to this quality management cycle (PDCA), there are no equal standards for patient-reported outcomes like quality of life (QoL). Therefore, the Tumour Centre Regensburg e.

Breast cancer survivors' recollection of their illness and therapy seven years after enrolment into a randomised controlled clinical trial.

Background: Little is known about the subjective experience of breast cancer survivors after primary treatment. However, these experiences are important because they shape their communication about their illness in everyday life, usage and acceptance of healthcare, and expectations of new generations of patients. The present study investigated this topic by combining qualitative and quantitative methods.

[Utilities: a solution of a decision problem?].

Utility is a concept that originates from utilitarianism, a highly influential philosophical school in the Anglo-American world. The cornerstone of utilitarianism is the principle of maximum happiness or utility. In the medical sciences, this utility approach has been adopted and developed within the field of medical decision making.

Differential effects of antibiotics in combination with G-CSF on survival and polymorphonuclear granulocyte cell functions in septic rats.

Background: In addition to their antimicrobial activity, antibiotics modulate cellular host defence. Granulocyte-colony stimulating factor (G-CSF) is also a well known immunomodulator; however little is known about the interactions of G-CSF with antibiotics. We investigated in septic rats the effects of two antibiotic combinations with G-CSF.

Quality of life diagnosis and therapy as complex intervention for improvement of health in breast cancer patients: delineating the conceptual, methodological, and logistic requirements (modeling).

Background And Aims: A system for quality of life (QoL) diagnosis and therapy in breast cancer patients was developed according to the Medical Research Council (MRC) framework of complex interventions. Along MRC's five phases in the continuum of evidence, the present paper deals with phase I: modeling (i.e.

Perioperative prophylaxis with granulocyte colony-stimulating factor (G-CSF) in high-risk colorectal cancer patients for an improved recovery: A randomized, controlled trial.

Background: We aimed to improve the postoperative outcome of high-risk patients (American Society of Anesthesiologists class 3 and 4) recovering from colorectal cancer surgery by using recombinant human G-CSF (filgrastim) as perioperative prophylaxis.

Methods: In a double-blinded, placebo-controlled trial, 80 patients undergoing left-sided colorectal resection were randomized to filgrastim or placebo. Filgrastim (5 mug/kg) or placebo was administered in the afternoon on day -1, 0, and +1 relative to the operation.

[The German program for disease management guidelines. Background, methods, and development process].

The Program for National Disease Management Guidelines (German DM-CPG Program) was established in 2002 by the German Medical Association (umbrella organization of the German Chambers of Physicians) and joined by the Association of the Scientific Medical Societies (AWMF; umbrella organization of more than 150 professional societies) and by the National Association of Statutory Health Insurance Physicians (NASHIP) in 2003. The program provides a conceptual basis for disease management, focusing on high-priority health-care topics and aiming at the implementation of best practice recommendations for prevention, acute care, rehabilitation and chronic care. It is organized by the German Agency for Quality in Medicine, a founding member of the Guidelines International Network (G-I-N).

[Diagnosis and therapy of illness-related quality of life in breast cancer patients. Protocol of a randomized clinical trial at the Regensburg Tumour Centre].

Background: The project conducted at the Tumour Centre in Regensburg aims to integrate quality of life (QL) diagnostics with the therapy of breast cancer patients and to evaluate the efficacy of QL diagnostics in the context of a randomized clinical trial.

Methods: The Regensburg Tumour Centre provides the infrastructure of the present project (telemedicine, project groups, quality circle). The treatment of breast cancer patients is based on the recent national breast cancer therapy guideline, including assorted QL-enhancing therapy options such as pain therapy, physiotherapy and lymphatic drainage, psychotherapy, social counselling and rehabilitation, nutrition and sports.

Early self-reported impairments in arm functioning of primary breast cancer patients predict late side effects of axillary lymph node dissection: results from a population-based cohort study.

Objectives: Improvements in the life expectancy of women with breast cancer raise important questions how to improve quality of life (QoL) for women sustaining complications and side effects of cancer treatment. The presented study examined the prevalence of arm morbidity in a cohort of primary breast cancer patients over time as a result of the extent of axillary lymph node dissection. Of particular interest is the question of using a recognized QoL assessment instrument at defined assessment points as an endpoint criteria of oncological treatment.

Granulocyte colony-stimulating factor prophylaxis improves survival and inflammation in a two-hit model of hemorrhage and sepsis.

Objective: We evaluated the effects of a granulocyte-colony stimulating factor (G-CSF) prophylaxis in two clinically relevant situations, hemorrhage on the day before infection (e.g., trauma) and acute hemorrhage followed subsequently by infection (e.

Evaluation of the McPeek postoperative outcome score in three trials.

Background: Postoperative outcome of patients is determined by recovery characteristics and self-reported quality of life. The first can be assessed with the McPeek score which values three aspects of recovery: mortality, postoperative critical care and duration of hospitalization.

Materials And Methods: We calculated the McPeek score of 669 patients in three trials: (1) colorectal cancer surgery, (2) antihistamine/volume loading in various operations, and (3) cholecystectomy.

Outcome and quality of life in medicine: a conceptual framework to put quality of life research into practice.

It is rather counterproductive to get caught up in never ending discussions on what quality of life (QOL) is and whether it can be assessed. This article is based on the idea that it is much more important to improve the conceptual frameworks that allow the use of the QOL concept in clinical practice. Survival of the QOL concept within the medical community will depend on its contributions to a better understanding of patients and to improving patient care.

Quality of life of patients with maxillofacial defects after treatment for malignancy.

Purpose: The purpose of the study was to investigate how cancer patients with maxillofacial defects evaluate their quality of life after prosthodontic therapy, complemented by a retrospective interview for judging the various therapy steps. The results were compared with a nontumor control group (multiple tooth extractions) and with population-based norm data.

Materials And Methods: A total of 34 patients were included in the study, 17 in each group.

Integrated outcome assessment after anterior cervical discectomy and fusion: myelocompression but not adjacent instability affect patient-reported quality of life and cervical spine symptoms.

Study Design: The authors conducted a cross-sectional study.

Objective: Integrated assessment of adjacent instability (AI), myelocompression (MC), magnetic resonance imaging (MRI) signs of myelopathy (MRISM), physician-assessed clinical signs and symptoms, including clinical signs of myelopathy (CSM), patients' self-reported symptoms and quality of life after anterior cervical discectomy and fusion (ACDF).

Materials And Methods: Fifty-four patients who had ACDF between 1986 and 1995 received MRI scans, conventional and flexion/extension radiographs to assess myelocompression, MRISM, fusion, and AI.

[Short version of the guideline "Early Detection of Breast Cancer in Germany"].

The aim of this evidence-, consensus- and outcome-based good clinical practice guideline is to help physicians, and women in making appropriate healthcare decisions about the early detection of breast cancer. The principle of early detection of breast cancer comprises the detection and diagnosis of pre-malignant breast tumours (UICC stage 0, carcinoma in situ) with a possible cancer risk reduction and the detection and diagnosis of breast cancer at an early stage (UICC stage 1) with a scientifically proven 90% chance of cure. By establishing a nation-wide comprehensive quality assurance program for the early detection of breast cancer this guideline lays the foundation for a timely reduction of breast cancer mortality and achievement of cure with less impairment of patient's quality of life.

[A concept for the implementation and evaluation of the guideline "Early Detection of Breast Cancer in Germany"].

Systematically developed, evidence- and consensus-based guidelines are important tools for improving health care services. The effectiveness of a guideline does not only relate to its methodological quality but also to the implementation strategy used. The following paper describes the systematic development of a strategy for implementing and evaluating the guideline "Early Detection of Breast Cancer in Germany" as part of a national project.

Dependence of positive effects of granulocyte colony-stimulating factor on the antibiotic regimen: evaluation in rats with polymicrobial peritonitis.

We tested the hypothesis that the ability of granulocyte colony-stimulating factor (G-CSF) to prevent death from fecal peritonitis is influenced by the composition of the antibiotic regimen with which it is administered. We used a rodent model of polymicrobial peritoneal contamination and infection and the concept of clinical modeling randomized trials (CMRTs), which includes the conditions of randomized, clinical trials and complex clinical interventions (e.g.

Mild preseptic hypothermia is detrimental in rats.

Objective: We evaluated the effects of mild hypothermia (32 degrees C), established before experimental intra-abdominal sepsis, on outcome, cytokine pattern, and muscle tissue oxygenation.

Design: Clinic modeling randomized laboratory trial.

Setting: University laboratory.

Deleterious effects of mild hypothermia in septic rats are ameliorated by granulocyte colony-stimulating factor.

Background: The authors studied the effects of mild hypothermia on the outcome in a rat model of intraabdominal sepsis and tested whether granulocyte colony-stimulating factor (G-CSF) augments the host response and improves outcome during mild hypothermia.

Methods: A rat model of peritoneal contamination and infection with human stool bacteria was used to simulate clinical trials that included increasing complexity. In trial 1, postoperative hypothermia (32 degrees C) was compared with normothermia (38 degrees C), without supportive treatment (10 rats per group).

The genetic background of hypertensive, septic rats determines outcome improvement with antibiotic and G-CSF prophylaxis.

Hypertension is proposed as a risk factor among others (high age, diabetes mellitus, and pre- and intraoperative bleeding) for adverse outcomes, such as severe infections, leading to sepsis and to multiple organ failure as the most deleterious complication. Hypertension was modeled with spontaneous hypertensive rats (SHR) and Dahl salt-sensitive (DS) rats and the infective complication by polymicrobial, peritoneal contamination, and infection (PCI). The concept of clinic modeling randomized trials was used to simulate clinical complexity, including a relevant antibiotic prophylaxis in combination with granulocyte-colony stimulating factor (G-CSF) and clinical trial conditions.

Relation between severe illness and non-completion of quality-of-life questionnaires by patients with rectal cancer.

Quality of life (QoL) is an important outcome measure in clinical studies, but interpretation is hindered by incompleteness of data. We addressed this issue in a population-based cohort study of 146 patients with newly diagnosed rectal cancer. QoL was assessed by means of European Organization for the Research and Treatment of Cancer questionnaires at discharge from hospital after primary treatment and then every 3 months for 2 years.

From clinical evidence to everyday practice: implementing findings from a cost-effectiveness analysis for endoscopic injection therapy for upper-gastrointestinal bleeding.

Background: A previous upper-gastrointestinal bleeding trial showed that patients treated with repeated fibrin glue injection for upper-gastrointestinal bleeding have significantly less rebleeding than those treated with polidocanol.

Objective: To analyse the cost and effectiveness of repeated fibrin glue injection and to investigate whether these results change physicians' attitudes.

Design: A retrospective random sample of five hospitals from the previous study, collection of cost identification, and follow-up data on 320 patients (155 in the polidocanol group, 165 in the fibrin glue group).